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|ClinicalTrials.gov Identifier: NCT04065997|
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment|
|Chronic Heart Failure||Device: HeartWare Ventricular Assist Device|
Apogee International is a prospective, non-interventional, post-market, multi-site registry, conducted within Medtronic's Product Surveillance Registry (PSR) Platform. Enrollment into Apogee International will be comprised of newly implanted, commercial use patients with the HeartWare Ventricular Assist Device System (HVAD System).
Sites selected to participate are expected to collect data in at least one of these five modules:
- Logfile Download;
- Anti-coagulation / Anti-platelet Management;
- Blood Pressure (BP) Management;
- Acoustic Spectrum Analysis;
- Infection Control
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Apogee International|
|Actual Study Start Date :||September 6, 2019|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2024|
Patients implanted with HVAD System
Patients intended to be implanted with a HeartWare HVAD per the current (local) guidelines, are eligible for enrollment into Apogee International and must be consented for Apogee International prior to the HVAD implant.
Device: HeartWare Ventricular Assist Device
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
Other Name: HVAD
- Major adverse events [ Time Frame: Implant to 12 months ]Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065997
|Contact: Tessa Geelen, PhD||0433566404 ext +email@example.com|